Abstract: Provided are ingestible polymeric formulations for the reduction of gastric volume in the treatment of overweight patients, and methods of use thereof. One method involves ingesting one or more ingestible tablets comprising cross-linked polymers formed in a packed mass within the one or more ingestible tablets into a stomach of the subject, wherein the cross-linked polymers comprise a polymer hydrogel comprising carboxymethylcellulose and a carboxylic acid; disintegrating an acid-sensitive gelatin coating such that the coating disintegrates in the gastric fluid and the cross-linked polymers disperse in the stomach; and maintaining the reduction in gastric volume such that a sensation of fullness is induced in the subject without releasing a drug which induces the sensation.

Abstract: An excipient, suitable for the preparation of pharmaceutical and/or cosmetic creams comprises an aqueous phase and organic phase comprising organic components. The components comprise natural or synthetic oil, one or more waxes, one or more organic esters. Each of the general formula R1 COO R2, wherein R1 and R2 are both, independently of one another, is a linear or branched alkyl group having 15 to 30 carbon atoms and sorbitan esters.

Abstract: The present invention relates to compositions of pharmaceutical agents in combination with additional pharmaceutical agents in a mixture of polyethylene glycol, polyvinylpyrrolidone, and propylene glycol and a process of making the compositions.

Abstract: The present invention relates to pharmaceutical formulations of highly active drugs with limited shelf-life in aqueous media, suitable to be administered by a caregiver person to a patient avoiding or minimizing the risk of exposure, contact or contamination of the caregiver person with the active product ingredient (API), preferably an EGFR-TKI such as afatinib dimaleate.

Abstract: The present invention discloses reverse/inverse micellar discontinuous cubic phase (Fd3m phase) composition for controlled release of therapeutic drugs or biologically active component and to the process for preparation thereof.

Abstract: This disclosure relates to a targeted PEGylated liposomal gemcitabine (PLG) composition comprising a PEGylated liposome encapsulating one or more agents comprising gemcitabine and a targeting moiety; pharmaceutical composition and methods comprising PLG or producing PLG; and manufacturing equipment for performing the methods.

Abstract: A method for producing porous particles includes (1) a step of preparing a solution of an amphiphilic substance by dissolving the amphiphilic substance in a mixed solvent capable of being freeze-dried, (2) a step of producing a precipitate containing the amphiphilic substance by cooling the solution obtained in step (1) to a temperature equal to or less than a phase separation temperature of the solution, and thereafter holding the solution at the temperature, and (3) a step of producing porous particles by freeze-drying the solution containing the precipitate obtained in the step (2).

Abstract: Methods and formulations are provided for treating migraine and other acute pain episodes using diclofenac, and formulations of diclofenac that provide both rapid and sustained relief from acute pain. Methods and formulations are also provided for treating symptoms that often accompany migraine and acute pain such as photophobia, phonophobia, nausea and vomiting.

Abstract: Provided is a molecular imprint polymer that is capable of acquiring stealth properties through a new mechanism. The molecular imprint polymer according to the present invention, which has a plasma protein recognition sites molecularly imprinted by a plasma protein thereon and contains a constituent derived from a biocompatible monomer, is an in vivo stealth nanoparticle to be used in intravascular delivery. As the plasma protein, albumin is preferred. When carrying a drug thereon, the in vivo stealth nanoparticle according to the present invention is usable as a drug for drug delivery system.

Abstract: A dry granulation process using a twin-screw extruder for granulating a powder mixture which includes at least one active ingredient and at least one carrier. The process includes steps of kneading the powder mixture in the screw barrel of the twin-screw extruder at a barrel temperature below a melting point of the at least one active ingredient and a melting point or a glass transition temperature of the at least one carrier to provide a kneaded powder mixture, and extruding the kneaded powder mixture to form granules. Granules and tablets produced using the dry granulation process in the twin-screw extruder are also provided.

Abstract: This invention relates to sustained release dosage forms comprising {1-{1-[3-fluoro-2-(trifluoromethyl)isonicotinoyl]piperidin-4-yl}-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]azetidin-3-yl}acetonitrile, or a pharmaceutically acceptable salt thereof, and doses and methods related thereto.

Abstract: The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.

Abstract: The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.

Abstract: The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.

Abstract: The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.

Abstract: The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.

Abstract: The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.

Abstract: The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.

Abstract: The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.

Abstract: The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.

Abstract: The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.

Abstract: The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.

Abstract: A self-assembled gel composition with enhanced adhesion to cartilage tissue is provided. A cationic agent co-self assembles with a generally regarded as safe (GRAS), low molecular weight (<2,500 Da) gelator, forming homogeneous self-supporting gel that can encapsulate one or more therapeutic agents for controlled release. The composition adheres to connective tissue, e.g., cartilage, to a greater extent and a greater length of time than a self-assembled gel from gelators alone. The composition is used to specifically target connective tissue and deliver one or more therapeutic, prophylactic, or diagnostic agents for controlled release to improve dosing efficacy.

Abstract: Gels are formed based on generally recognized as safe (GRAS) low molecular weight amphiphilic molecules in a self-assembly process with limited or no heating. A selective range of ratios between an organic solvent and water, or an aqueous solution, in the medium, allows for the GRAS low molecular weight amphiphiles to form a homogeneous self-supporting gel encapsulating agents to be delivered under very mild conditions. Proteins including enzymes, antibodies, and serum albumin are loaded in the self-assembled gels to provide sustained and/or responsive delivery. The encapsulated proteins retain at least 70%, 80%, or 90% of their activity over days in various storage conditions.

Abstract: Abuse-resistant oral dosage forms suitable for administration of pharmacologically active agents are provided.

Abstract: The present invention provides pharmaceutical compositions suitable for oral delivery and methods of treating subjects in need thereof. The pharmaceutical compositions of the present invention enhance bioavailability of at least one compound classified as BCS Class II, BCS Class III or BCS Class IV.

Abstract: The present invention provides microcapsules in which oil comprising unsaturated fatty acids is encapsulated, such as polyunsaturated fatty acids (PUFAs), the invention further relates to a process for preparing the microcapsules. The process comprises the step of adding a plasticizer to the ingredients forming an emulsion, which emulsion may be spray-dried in a subsequent step to form the microcapsules. The presence of the plasticizer and of other constituents of the emulsion and/or the microcapsules synergistically interact so as to results in encapsulated PUFAs having an increased stability and a reduced off-taste.

Abstract: The present invention is a preparation containing a statin-encapsulated nanoparticle obtained by encapsulating statin in a nanoparticle containing a bioabsorbable polymer. The nanoparticle has a number average particle diameter of less than 1000 nm. The preparation is used to enhance the function of a stem cell. The present invention is a stem cell with an enhanced function. The stem cell takes up and contains the statin-encapsulated nanoparticle.

Abstract: The present invention provides a microparticle comprising at least one biocompatible polymer, the microparticle encapsulating at least one nanoparticle, the nanoparticle comprising: (i) a core comprising a metal and/or a semiconductor; and (ii) a corona comprising a plurality of ligands covalently linked to the core, wherein said ligands comprise at least one carbohydrate and/or glutathione. The nanoparticle may additionally comprise a biologically active agent or detectable label covalently linked or non-covalently bound to said corona and/or said core. Also disclosed are pharmaceutical compositions comprising the microparticles, processes for their production and uses of the microparticles in methods of therapy.

Abstract: Network materials which exhibit both shear thinning and self-healing properties are disclosed. The networks contain particles and gel-forming compounds. The networks are useful for a variety of biomedical uses, including drug delivery.

Abstract: The present invention provides a process for preparing the nanoparticles. The process comprises first forming a water-in-oil emulsion from chitosan lactate, amoxicillin, dioctyl sodium sulfosuccinate, glutaraldehyde or bis[sulfosuccinimidyl] suberate, and oil, and sonicating the mixture of to form nanoparticles comprising chitosan crosslinked by dioctyl sodium sulfosuccinate and glutaraldehyde or by dioctyl sodium sulfosuccinate and bis[sulfosuccinimidyl] suberate, wherein the nanoparticles have an average diameter of 100-600 nm and have amoxicillin entrapped by the crosslinked chitosan. The present invention is also directed to nanoparticles comprising crosslinked chitosan and amoxicillin, wherein amoxicillin is entrapped by the crosslinked chitosan. The nanoparticles have an average diameter of 100-600 nm, and the entrapped amoxicillin is at least 5% (w/w) of the total weight nanoparticles.

Abstract: Provided are methods of using curcuphenol compounds to increase expression of major histocompatibility complex class I (MHC-I) antigen in cells, particularly on the surface of diseased cells such as cancer cells, and thereby increase the immunogenicity of the cells. Also provided are pharmaceutical compositions that comprise curcuphenol compounds and methods of use thereof, for instance, to treat various cancers, alone or in combination with other therapies.

Abstract: Ternary composition of CoQ10, one or more specific hydroxypropylcellulose (HPC) based amphiphilic carriers and one or more adjuvants selected from the group of sucrose esters.

Abstract: There is disclosed a method for treating disorders modulated by at least opiate receptor activity or monoamine activity, including acute and chronic pain, comprising administering a pharmaceutical formulation comprising O-desmethyltramadol. Methods are also provided that are effective for overcoming resistance to tramadol in patients.

Abstract: Disclosed herein is a composition for oral administration of O-desmethyltramadol that is effective for overcoming resistance to tramadol in patients.

Abstract: An enteric-coated bead dosage form of cysteamine, and related methods of manufacture and use, are disclosed.

Abstract: An enteric-coated bead dosage form of cysteamine, and related methods of manufacture and use, are disclosed.

Abstract: An enteric-coated bead dosage form of cysteamine, and related methods of manufacture and use, are disclosed.

Abstract: Provided herein is an ophthalmic composition including a therapeutic active agent and an anti-inflammatory agent, in which the active agent is at least about 0.01% w/v of chlorhexidine, derivatives, or analogues of chlorhexidine, or a pharmaceutically acceptable salt, solvent, hydrate, or polymorph thereof. Methods for treating or preventing ocular disease or infection in a subject in need thereof are also provided. The method may include administering to an eye of a subject an ophthalmic composition including chlorhexidine, derivatives, or analogues of chlorhexidine, or a pharmaceutically acceptable salt, solvent, hydrate, or polymorph thereof, and an anti-inflammatory agent. The chlorhexidine, derivatives, or analogues of chlorhexidine, or a pharmaceutically acceptable salt, solvent, hydrate, or polymorph thereof and the anti-inflammatory agent are present in an amount effective to treat or prevent the ocular disease or infection in a subject in need thereof.

Abstract: 2-hydroxy-benzoic anilide compounds and derivatives, compositions thereof, and methods for treating metabolic diseases and cancer through uncoupling mitochondria.

Abstract: The invention features a method for inhibiting one or more voltage-gated ion channels in a cell by contacting the cell with (i) a first compound that activates a channel-forming receptor that is present on nociceptors and/or pruriceptors; and (ii) a second compound that inhibits one or more voltage-gated ion channels when applied to the internal face of the channels but does not substantially inhibit said channels when applied to the external face of the channels, wherein the second compound is capable of entering nociceptors or pruriceptors through the channel-forming receptor when the receptor is activated. The invention also features a quarternary amine derivative or other permanently or transiently charged derivative of a compound that inhibits one or more voltage-gated ion channels when applied to the internal face of the channels but does not substantially inhibit said channels when applied to the external face of the channels.

Abstract: Sodium ibuprofen compositions and methods of manufacturing tablets and caplets comprising sodium ibuprofen are described. The formulation is advantageous because it allows for the formation of tablets having low sodium content and further provides tablets exhibiting improved physical stability, high tablet hardness and high strength, coupled with excellent dissolution and bioavailability characteristics.

Abstract: The present invention is related to a combination comprising a COX inhibitor, a Mg2+ source, and ascorbic acid or a stereoisomer or a pharmaceutically acceptable salt thereof, uses and pharmaceutical composition thereof.

Abstract: Compositions for reducing the frequency of urination and methods of manufacturing the compositions are disclosed. The compositions comprises a first component having an immediate-release subcomponent and an extended-release subcomponent, wherein the first component is formulated to release the subcomponents immediately after administration; and a second component comprising an immediate-release subcomponent and an extended-release subcomponent, wherein the second component is formulated for a delayed-release of the subcomponents.

Abstract: Compositions for reducing the frequency of urination and methods of manufacturing the compositions are disclosed. The compositions comprises a first component having an immediate-release subcomponent and an extended-release subcomponent, wherein the first component is formulated to release the subcomponents immediately after administration; and a second component comprising an immediate-release subcomponent and an extended-release subcomponent, wherein the second component is formulated for a delayed-release of the subcomponents.

Abstract: The disclosure provides oral cysteamine and cystamine formulations useful for treating cystinosis and neurodegenerative diseases and disorders. The formulations provide controlled release compositions that improve quality of life and reduced side-effects.

Abstract: The disclosure provides oral cysteamine and cystamine formulations useful for treating cystinosis and neurodegenerative diseases and disorders. The formulations provide controlled release compositions that improve quality of life and reduced side-effects.

Abstract: The disclosure provides oral cysteamine and cystamine formulations useful for treating cystinosis and neurodegenerative diseases and disorders. The formulations provide controlled release compositions that improve quality of life and reduced side-effects.

Abstract: The present invention discloses novel agents and methods for diagnosis and treatment of melanoma. Also disclosed are related arrays, kits, and screening methods.

Abstract: The present invention includes a pharmaceutical composition, and methods of making and using, a pharmaceutical composition comprising one or more thyroid hormone(s) or analogs thereof, wherein a first portion of thyroid hormone(s) is formulated for immediate release and a second portion of thyroid hormone(s) is formulated of modified release, e.g., by forming a drug-resin particle with an ion exchange resin.